Randomization to Endovascular Treatment Alone or Preceded by Systemic Thrombolysis With Tenecteplase in Ischemic Stroke

Recruiting Phase 3 Interventional Study
Stroke, Ischemic Stroke, Acute
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 85
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
398 (estimated)
Sponsor
Hospital Moinhos de Vento · Other
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About This Trial

A phase III randomized, multi-center, double-blinded, placebo-controlled clinical trial that will examine two strategies for the treatment of acute ischemic stroke associated with a large vessel anterior occlusion within 4.5 hours from symptoms onset: direct endovascular treatment vs. endovascular treatment preceded by intravenous tenecteplase.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Acute ischemic stroke where a patient is eligible for IV thrombolytic treatment within 4.5 hours of stroke onset. * No significant pre-stroke functional disability (mRS ≤ 1) * Baseline NIHSS scores obtained before randomization must be equal to or higher than 6 points * Age eq…
Contacts

Octavio M Pontes-Neto, MD, PhD

+551636053779

opontesneto@fmrp.usp.br

CONTACT

Leonardo A Carbonera, MD, MSc

+555135378195

leonardo.carbonera@hmv.org.br

CONTACT